Rf Cal RF2301
Rf Cal RF2301 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K972220 on 9 Sep 1997 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05055273205039), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05055273205039 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK972220 | Date9 Sep 1997 | StatusActive |
Official records
- AccessGUDID record 05055273205039
- FDA 510(k) database K972220
Across registries
- FDA 510(k) K972220 decided 9 Sep 1997 Active
- FDA GUDID UDI-DI 05055273205039 listed 24 Sep 2016 Listed
Recalls
-
- Terminated Z-0282-2020
The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.
Timeline
- Cleared FDA 510(k) K972220
- Listed FDA GUDID 05055273205039
- Recall initiated FDA recalls Z-0282-2020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rf Cal
- Generic name
- Rheumatoid factor IVD, calibrator
- Model / Ref / Catalog
- RF2301
- Primary DI / UDI-DI
- 05055273205039
- 510(k) Number
- FDA product code
- DHR
- GMDN term
- Rheumatoid factor IVD, calibrator
- Device class
- Class II
- Regulation number
- 866.5775
- GUDID distribution status
- In Commercial Distribution